Nocdurna Approved to Treat Nocturia
June 21, 2018 – The U.S. FDA has approved Nocdurna® (desmopressin acetate), manufactured by Ferring Pharmaceuticals, to treat adults who experience nocturia (excessive nighttime urination) due to nocturnal polyuria (an alteration in the usual ratio of day-to-night urine production).
In clinical trials, Nocdurna reduced the need to urinate overnight by 52% in women and 43% in men compared to baseline. The sublingual tablets dissolve rapidly under the tongue and are absorbed directly into the bloodstream. Recommended dosing for women is 27.7mcg daily one hour before bedtime. For men, the recommended dose is 55.3mcg on the same schedule.
Nocdurna carries a black box warning, as it may cause potentially fatal hyponatremia (low sodium concentration in the blood). The boxed warning cautions that use of the drug is contraindicated in patients at risk for hyponatremia, and serum sodium concentration should be checked and verified to be normal in all patients before starting treatment. Nocdurna may need to be discontinued on either a temporary or permanent basis if hyponatremia occurs during treatment.
Desmopressin acetate, Nocdurna’s active ingredient, was first approved by the FDA in 1978. It is available as a nasal spray under the brand name Noctiva® from Serenity Pharmaceuticals, also for the treatment of nocturia. Other available desmopressin acetate products include solutions for injection, which can be used to treat conditions such as hemophilia, von Willebrand’s disease, and diabetes insipidus.
Ferring Pharmaceuticals plans to launch Nocdurna during the second half of 2018. Pricing information has not yet been announced.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.